The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

• ClinicalTrials.gov Identifier: NCT03057080
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Sponsor: University of Crete
• Information provided by (Responsible Party): Izolde Bouloukaki, University of Crete

Tracking Information

• First Submitted Date: February 12, 2017
• First Posted Date: February 17, 2017
• Last Update Posted Date: February 17, 2017
• Actual Study Start Date: June 1, 2009
• Actual Primary Completion Date: June 1, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2017)

Number of patients with ulcer healing [ Time Frame: 2 years ]

Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 14, 2017)

• Amputation free survival [ Time Frame: 2 years ]
  Number of months without amputation
• Number of patients with all-cause mortality [ Time Frame: 2 years ]
  Number of patients with all-cause mortality after PTA
• Number of participants with Major adverse events [ Time Frame: 2 years ]
  Number of participants with Major adverse events from PTA
• Number of patients with 30-day morbidity and mortality [ Time Frame: 30 days ]
  30-day morbidity and mortality from PTA
• Number of patients requiring re-intervention [ Time Frame: 2 years ]
  umber of patients requiring PTA re-intervention

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
• Official Title: Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
• Brief Summary: The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

Detailed Description

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers.

Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ischemic Foot Ulcers

Intervention

Procedure: Percutaneous transluminal angioplasty (PTA)

The main goal of the angioplasty (which was also the definition of technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or plantar arch.

Study Arms

PTA procedure

Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer

Intervention: Procedure: Percutaneous transluminal angioplasty (PTA)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2017): 161
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 1, 2016
• Actual Primary Completion Date: June 1, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• newly diagnosed patients with ischemic foot ulcer and
• patients aged 18 years or older.

Exclusion Criteria:

• refusal to participate
• refusal of PTA therapy
• lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging
• absolute contraindication to contrast media injection, as determined by the investigator
• uncontrollable coagulopathy
• unwilling or unable to provide informed consent or return for required follow-up evaluations and
• previous or concurrent participation in another clinical research study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03057080
• Other Study ID Numbers: PTA1A
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Izolde Bouloukaki, University of Crete
• Study Sponsor: University of Crete
• Collaborators: Not Provided

Investigators

• Study Chair: Dimitrios Tsetis, MD, PhD; University of Crete

• PRS Account: University of Crete
• Verification Date: February 2017